RESERCO SL

Veterinary Regulatory Services

ABOUT US

Reserco is a contract consultancy which offers Research and Development (R+D) services to veterinary pharmaceutical companies.

Focusing on providing expert advice in Regulatory Affairs and Project Management, it supports companies worldwide in European and International markets.

PRODUCT DEVELOPMENT

Support in submitting SME applications to European Authorities

Support in MUMS applications

Evaluation of GAP analysis

Product development plan (studies to be conducted, cost estimation, timelines)

Selection of partners (define activities and requirements)

REGULATORY AFFARIS

Regulatory strategies (MUMS, generics, innovative products)

Regulatory advice in CP, DCP, MRP and National procedures

Consultancy with regulatory authorities

Preparation of the Marketing Authorisation dossiers documentation

Preparation and submission of regulatory documents in vNeeS validated format

Quality, Safety and Efficacy Expert reports

Pre-submission meetings

Manage national and international applications for Marketing Authorization

Dealing with authorities questions

Follow-up of the procedure until its resolution

Variations and Renewals

Evaluate and update dossiers into current standards

Transfer and update paper based dossiers into new electronic format

Scientific Advice (request, assistance and defence)

MRL application dossiers

EFFICACY AND SAFETY STUDIES

Protocol elaboration and final studies reports

Residue studies

Tolerance in Animal Species (TAS) Studies

Pharmacokinetic and pharmacodynamics (PK/PD) studies

Efficacy field and controlled studies

Development of the pre-clinical and clinical trials

Monitoring of the trials

Regular contact with veterinaries/investigators during the study

CRO contract

PROJECT MANAGEMENT

Study outlines

Coordination of the development plan

Coordinate timelines for studies

Coordinate activities with other partners

Evaluation and Selection of suppliers for studies

Monitoring studies

Elaboration and review protocols

Elaboration and review of final study reports

Provide updates of the project status

Support solving problems

QUALITY SERVICES

Pharmaceutical development

Analytical development

Complete quality studies development

SERVICES FOR ALL TYPE OF STUDIES

Study design

Protocol Development

Import licenses

Selection of the site

Set up of Studies

Training of Study Participants

Monitoring of Studies including regular site visits

Statistical analyses and Interpretation

Final Study Report

GMP compliant Contract Manufacturing

Regular contact with sites during the studies

Consultancy of protocols and reports

CARE PRODUCTS

European Registration

European Variations and Renewals

Scientific advice

Contact with the competent authorities

RESERCO - RESEARCH and DEVELOPMENT

CO-WORKING

More than 20 years of experience. Contact with the European National Authorities, European Medicines Agency (EMA) and non- European countries agencies (Turkey, Russia, South Africa, Morocco). Contact with research institutes (CROs), veterinaries and experts to develop quality, safety and efficacy tasks.